Science in Society Archive

Genetically Modifying Genes and Scientific Evidence

Review of Altered Genes, Twisted Truth, by Steven M. Druker,  Clear River Press, Salt Lake City UT, 2015. ISBN 978-0-9856169-1-5 (hardcover), 978-0-9856169-0-8 (softcover). Prof Peter Saunders

Altered Genes, Twisted Truth, by Steven M. Druker

According to the advocates of genetic engineering, GMOs have been proven by countless rigorous trials to be safe, no humans or even animals have ever been harmed by them, genetic modification is no different from the natural and artificial breeding that has been going on for millennia, it has produced crops with all sorts of desirable properties such as drought resistance, we cannot hope to feed the world without it, and so on.

These statements are all false. And in Altered Genes, Twisted Truth, Steven Druker, a lawyer, shows them to be false exactly as if he were in a courtroom. He has collected a vast amount of documentary evidence: scientific papers and also internal reports and memos. He has interviewed many of the people who were involved and he explains the science so that lay readers can follow the arguments.

The book is a surprisingly good read, considering how long it is and the amount of detail it contains, but it is also a valuable reference text. When the GMO lobby confidently state that genetic engineering is the same as ordinary breeding, this is where you can learn why it is not. When they describe the work of Arpad Pusztai or of Gilles-Eric Séralini as ‘discredited’, you can find out what actually happened, and why neither result has ever been properly challenged, let alone refuted.

It’s not just a matter of one person’s word against another. Unlike the GM lobby, Druker presents solid evidence for what he claims. It’s there in detail and it is fully referenced; you are welcome to check it for yourself.

To give you a flavour of the book, here are brief outlines of two of the early chapters, one on Asilomar and one on tryptophan. Both stories are very important in the history of genetic engineering, but they are seldom mentioned today. When they are, the usual spin is that a few scientists raised their concerns at a meeting but soon accepted that these were unwarranted, and that the tryptophan incident had nothing to do with GM. In both cases, the truth is quite different.

Asilomar

Forty years ago, when transferring genes from one organism to another was first becoming a standard research technique, scientists naturally began to worry about its potential hazards. The US National Academy of Sciences (NAS) appointed a commission to look into the issues, and this led to a letter to the journal Science [1] and then, in February 1975, a meeting of over a hundred scientists at the Asilomar Conference Center in Monterey, California. The outcome was a statement [2] with a list of safety guidelines, including the requirement that research should be carried out using only disabled bacteria that could not survive outside the laboratory. Just the sort of thing you would expect when there is a possibility of danger. Chemists, after all, work in specially designed laboratories, not out in the open, and they have to make special arrangements to dispose of the waste from their experiments; they are not allowed to pour it down the sink and into the public sewers.

The Asilomar guidelines were, however, soon abandoned. They are seldom mentioned today, and if you have heard of them at all you’ve probably been told that while they were an understandable reaction to a new technology, they were soon shown to be unnecessary because it was conclusively demonstrated that the techniques pose no significant hazards.

Druker, who has looked carefully through the published records and interviewed many of those who were around at the time, tells a very different story. One of his key points is that the claim that genetic engineering was safe was largely based on research involving only one bacterium, E. coli K-12. But K-12 had been used in laboratories for many years and was relatively weak, i.e. it would be unlikely to survive outside the laboratory. So while the release of a genetically modified K-12 into the environment might not be dangerous, that would be reassuring only if all future research were confined to K-12. Even then, there would remain the risk that the transferred gene would pass into another, stronger organism.

Yet molecular biologists used, and continue to use, this evidence to justify their claim that genetic engineering involves no special risks and that GM organisms require no more testing than those that have been conventionally bred; they are, in the words of the US Food Additive Amendment of 1958, “generally recognized as safe” (GRAS) and consequently exempted from testing.

It’s easy to understand why so many molecular biologists, rushing to push ahead in what they saw as an important and exciting new area, allowed their enthusiasm to cloud their judgement. They could also see the prospect of turning their research into profit, and that made them even less anxious to think about the dangers. Crucially, they managed to convince the Reagan administration that there was money to be made and jobs to be created and that the US must not be left behind. That, combined with the Reagan-Thatcher policy of relaxing all regulation – in banks as well as in molecular biology – made support for genetic engineering a part of government policy. The US government has consistently backed the GM industry and has used its strength to pressure other countries into accepting GM crops. The Asilomar guidelines and the concerns that led to them have been totally forgotten.

Druker gives many examples of how scientists working for regulatory bodies such as the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) were pointing out the dangers of GM but to their great frustration, only to have their concerns dismissed by their bosses. They were right to be frustrated, but they should not have been so surprised. Once a government has decided on a policy, it expects all its employees – scientists as much as anyone else -- to support it; In the words of a policy adviser to the President of the European Commission, from that point on “scientific evidence is less up for debate.”  ([3], [4]  Politically Correct Science for the Masses, SiS 61).

The chief role of a regulator is to ensure a level playing field among producers by preventing anyone gaining an advantage by doing something that the consensus within the industry agrees is unsafe. Whether that consensus is right or not is a different matter altogether. Governments and industry are always trying to assure us that the regulators are there to protect the public but this is true only in a limited sense.

Tryptophan

In 1989, physicians in the US began to report a new disease that typically involved severe muscle and joint pain and swelling of the legs and arms, sometimes with more serious symptom as well. It was soon found that all the victims had been taking an amino acid, L-tryptophan (LT) as a supplement, and while a number of companies were producing it, all the people suffering from this new disease had been taking LT supplied by one manufacturer, Showa Denko KK. And Showa Denko was the only manufacturer using genetically modified bacteria in the production process.

Like the Asilomar guidelines, the story of tryptophan is seldom mentioned today. If it is, we are assured that problem with LT was nothing to do with genetic engineering. The batch had become contaminated during processing; the fact that it had been produced by GM bacteria was irrelevant.

Druker describes, and refutes, in detail the many arguments used by the FDA in an attempt to rule out GM as a cause. And it was the FDA - which we expect to be striving to protect public safety - that was working so hard to defend genetic engineering. Showa Denko were not really interested in arguing about what had gone wrong because they were going to have to pay compensation whatever the cause turned out to be.

To give just one example of the efforts made to cloud the issue, the GM lobby has always claimed that while the epidemic occurred only after the GM bacteria known as Strain V were introduced, there were in fact some cases of EMS that occurred before that. That might seem to rule out genetic modification as a cause, except that – as the name suggests but the FDA somehow omitted to mention – there were four earlier strains of the bacteria and all but the first were GM. Contrary to what the FDA claimed, all the LT supplied by Showa Denko had been produced using GM bacteria.

In the light of all the evidence that Druker so meticulously documents, it is hard to reach any conclusion other than that it was the use of GM bacteria that caused the EMS outbreak. But that’s not the story that we are told today.

More examples

The rest of the book is no more edifying than these early chapters. Druker shows in detail how regulatory agencies all over the world have misused the evidence and twisted the truth to allow GM crops to be grown without restriction. For the most part they have not carried out their own research but relied on assurances from the industry.  He describes how two scientists, Arpad Pusztai and Gilles-Eric Séralini, who had the courage to report what they had found, were attacked by the biotech industry and its friends in the science academies. Those scientists who have been so ready to jump on the pro-GM bandwagon would do well to read Druker’s book, and find out what it is they have committed themselves to. They could begin by reading the papers by Pusztai [5] and Séralini [6], which most of them clearly have not done. (That explains why so many of them criticise Séralini for not following the OECD protocol for experiments on cancer when in fact his research was concerned with toxicity, for which the protocol is different. You only have to read the title of the paper to discover that.)

Altered Genes, Twisted Truth was published early in 2015, but there are already at least two more examples that could have been added. They are about glyphosate, and are relevant to GMOs because one of the most profitable applications of genetic engineering has been to produce varieties of maize, soya and cotton that are tolerant of glyphosate, the active ingredient of many herbicides including Monsanto’s Roundup.

It was recently announced that an EU study [7] has concluded that glyphosate is safe. The announcement explained that the European Commission had delegated the work to Germany as “Rapporteur Member State.” What it did not explain was that the German Federal Institute for Risk Assessment had delegated it to a body called the Glyphosate Task Force, which according to its web site is a consortium of chemical and biotech companies “joining resources and efforts in order to renew the European glyphosate registration with a joint submission.” ([8], [9] Scandal of Glyphosate Re-assessment in Europe, SiS 64)  It’s like asking the fox to advise on the security of the henhouse.

The International Agency for Research on Cancer (IARC) has recently published a report in which a panel of 17 experts from 11 countries and chaired by Aaron Blair, formerly the top scientist on pesticides and cancer at the US National Cancer institute, unanimously agreed to reclassify glyphosate as “probably carcinogenic to humans”. ([10], [11] Glyphosate ‘Probably Carcinogenic to Humans’ Latest WHO Assessment, SiS 66)

Monsanto immediately demanded that the report be retracted; this seems to have become their standard response to any scientific result they do not like.  But the IARC is part of the WHO, and the WHO refused to be bullied. The report remains a WHO document and it is already starting to have an effect. At the time of writing, Colombia has stopped spraying glyphosate to destroy coca crops, Bermuda and Sri Lanka have banned the import of glyphosate products, and consumer protection ministers in Germany have called for a ban on their use by private individuals (see [12] Fallout from WHO Classification of Glyphosate as Probable Carcinogen, SiS 67).

To conclude

Altered Genes, Twisted Truth makes some demand on the reader, but little in the way of previous scientific knowledge. Anyone who reads Science in Society will have no difficulty with it and will learn a great deal, whether they are scientists or not. Druker’s primary target is the decision makers.

If they are in favour of GMOs, as many of them are, that is because they have been advised by experts but failed to take into account that experts have their own agendas. If you have built up a career in some branch of science, and even more so if you have a financial stake in it, it is only to be expected that you will be very optimistic about its potentialities and be inclined to play down its drawbacks, especially its dangers. Druker is not asking the decision makers to believe him instead of their advisers. He is inviting them to read the evidence for themselves and make up their own minds. That, after all, is what decision makers are there for.

Article first published 22/06/15


References

  1. Berg P, Baltimore D, Boyer HW, Cohen SN, Davis RW, Hogness DS, Nathans D, Roblin R, Watson JD, Weissman S and Zinder ND (19740. Potential biohazards of recombinant DNA molecules.' Science 185, 303.
  2. Berg P, Baltimore D, Brenner S, Roblin RO and Singer M (1975). Summary Statement of the Asilomar Conference on Recombinant DNA Molecules. Proc. Nat. Acad. Sci. 72, 1981-1984.
  3. Schmitt D. The great divide. The Scientist, 1 December 2013. http://www.the-scientist.com/?articles.view/articleNo/38364/title/The-Great-Divide/  20/1/14.
  4. Saunders PT (2014). Politically correct science for the masses. Science in Society 61, 2-3.
  5. Ewen SW and Pusztai A (1999). Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine'. Lancet 354, 1353–4. doi:
  6. Séralini GE, Clair E, Mesnage R, Gress S, Defarge N, Malatest M, Hennequin and Spiroux de Vendômois J (2014). Republished study: long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Environmental Sciences Europe 26:14. doi:10.1186/s12302-014-0014-5
  7. Bundesinstitut für Risikobwertung (2014). Renewal Assessment Report on Glyphosate. Vol. 1.
  8. Glyphosate Task Force (2013). The European Glyphosate Task Force. http://www.glyphosatetaskforce.org/
  9. Ho MW and Swanson N. Scandal of glyphosate reassessment in Europe.      Science in Society 63, 8-9, 2014.
  10. Guyton KZ, Loomis D, Grosse Y, El Ghissassi F, Benbrahim-Talaa L, Guha N, Scocciant C, Mattock and Straif K (2015). Carcinogenicity of tetrachlorvinphos, parathion, malathion, diazinon, and glyphosate. Lancet Oncology 16, 490-491.
  11. Ho MW and Swanson N. Glyphosate “probably carcinogenic to humans”: Latest WHO assessment. Science in Society 66 16-23, 2015.

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judith weiss Comment left 23rd June 2015 05:05:27
thank you for the courage to publish this

susan Comment left 23rd June 2015 05:05:18
McDonald's partners with gas tycoon to open first store in Kazakhstan American fast-food giant says deal with Kairat Boranbayev – who is related by marriage to the country’s authoritarian president – will help to build brand. EurasiaNet.org reports I have come across someone who also holds much of the original information on GMO policy. This is how it went: Michael Taylor: He received a B.A. degree in political science from Davidson College and a law degree from the University of Virginia. In 1976, after passing the bar examination, Taylor became a staff attorney for the FDA, where he was executive assistant to the Commissioner.[1][2] In 1981 he went into private practice at King & Spalding, a law firm, one client of which was the biotechnology company Monsanto,[3] where he established and led the firm's food and drug law practice.[1][2] Original letter sent from Jim Maryanski dated October 7, 1991 Note to Mr. Taylor Subject: Food Biotechnology Policy Development I suggest that you consider discussing your goals for developing our food biotechnology policy by the end of this year with Dr. Guest, CVM*. Most crops developed by new biotechnology that will be used for human food will also be used as feed for animals. For this reason, I have been coordinating reviews and policy development between CFSAN and CVM, and it will be useful for both Centers to cooperate on a number of issues, especially those related to environmental sciences. I think CVM would appreciate hearing your thoughts. Jim Maryanski CFSAN Biotechnology Coordinator *Dr. Guest Gerald B. Guest, DVM Acting Director, Center for Veterinary Medicine August 1980 – April 1982 said Monsanto held meetings around the country where "the emphasis was clearly to promote the safety and effectiveness of BST, particularly Monsanto's product, to practicing veterinarians." Some of the meetings were attended by staff members from Dr. Guest's agency. Last November, the Foundation on Economic Trends, a Washington advocacy group leading a national campaign against the hormone, accused the four companies that make the chemical, plus dairy trade associations, of promoting the drug, and threatened to sue the F.D.A. if the agency did not take action to stop the promotion. The critics' opposition is based on fear of the health effects on humans who consume milk from cows that have been injected with the hormone. Bonnie Aikman, an spokeswoman for the F.D.A., said the reprimand of Monsanto was not in response to the group's objections but was a result of the F.D.A.'s own investigation. The drug, the first genetically engineered hormone to undergo the Government drug approval process, is at the center of a struggle over the future of biotechnology in agriculture. Hormones From Bacteria. In the F.D.A.'s nearby offices, not everyone was so sure. Among them was Dr. Louis J. Pribyl, one of 17 government scientists working on a policy for genetically engineered food. Dr. Pribyl knew from studies that toxins could be unintentionally created when new genes were introduced into a plant's cells. But under the new edict, the government was dismissing that risk and any other possible risk as no different from those of conventionally derived food. That meant biotechnology companies would not need government approval to sell the foods they were developing. "This is the industry's pet idea, namely that there are no unintended effects that will raise the F.D.A.'s level of concern," Dr. Pribyl wrote in a fiery memo to the F.D.A. scientist overseeing the policy's development. "But time and time again, there is no data to back up their contention." Dr. Pribyl, a microbiologist, was not alone at the agency. Dr. Gerald Guest, director of the center of veterinary medicine, wrote that he and other scientists at the center had concluded there was "ample scientific justification" to require tests and a government review of each genetically engineered food before it was sold. Three toxicologists wrote, "The possibility of unexpected, accidental changes in genetically engineered plants justifies a limited traditional toxicological study." The scientists were displaying precisely the concerns that Monsanto executives from the 1980's had anticipated - and indeed had considered reasonable. But now, rather than trying to address those concerns, Monsanto, the industry and official Washington were dismissing them as the insignificant worries of the uninformed. Under the final F.D.A. policy that the White House helped usher in, the new foods would be tested only if companies did it. Labeling was ruled out as potentially misleading to the consumer, since it might suggest that there was reason for concern. "Monsanto forgot who their client was," said Thomas N. Urban, retired chairman and chief executive of Pioneer Hi-Bred International, a seed company. "If they had realized their client was the final consumer they should have embraced labeling. They should have said, `We're for it.' They should have said, `We insist that food be labeled.' They should have said, `I'm the consumer's friend here.' There was some risk. But the risk was a hell of a lot less." Even some who presumably benefited directly from the new policy remain surprised that it was adopted. "How could you argue against labeling?" said Roger Salquist, the former chief executive of Calgene, whose Flavr Savr tomato, engineered for slower spoilage, was the first fruit of biotechnology to reach the grocery store. "The public trust has not been nurtured," he added. In fact, the F.D.A. policy was just what the small band of activists opposed to biotechnology needed to rally powerful global support to their cause. "That was the turning point," said Jeremy Rifkin, the author and activist who in 1992 had already spent more than a decade trying to stop biotechnology experiments. Immediately after Vice President Quayle announced the F.D.A.'s new policy, Mr. Rifkin began calling for a global moratorium on biotechnology as part of an effort that he and others named the "pure food campaign." He quickly began spreading the word to small activist groups around the world that the United States had decided to let the biotechnology industry put the foods on store shelves without tests or labels. Mr. Rifkin said that he got support from dozens of small farming, consumer and animal rights groups in more than 30 countries. In Europe, these small groups helped turn the public against genetically altered foods, tearing up farm fields and holding protests before television cameras. If the F.D.A. had required tests and labels, Mr. Rifkin said, "it would have been more difficult for us to mobilize the opposition." Today, the handful of nonprofit groups that joined Mr. Rifkin's in lobbying the F.D.A. for stronger regulation in 1992 have multiplied to 54. Those groups, including the Sierra Club, Friends of the Earth, the Natural Resources Defense Council, Public Citizen and the Humane Society of the United States, signed a petition this spring demanding that the government take genetically engineered foods off the market until they are tested and labeled. "There is absolutely no question that the voluntary nature of the policy was unacceptable to many," said Andrew Kimbrell, one of the early activists to oppose biotechnology and now the executive director of the Center for Food Safety, which filed the petition. The F.D.A. policy has also helped organizations like Mr. Kimbrell's raise money. In late 1998 groups opposed to biotechnology approached the hundreds of foundations that give regularly to environmental causes and told them about the government's decision to let the companies regulate themselves. Since then, the foundations have given the groups several million dollars out of concern over the policy, said Christina Desser, a lawyer in San Francisco involved in the fund-raising effort. There was also an about-face in the approach to dealing with overseas markets. As the Clinton administration came to Washington, Monsanto maintained its close ties to policy makers - particularly to trade negotiators. For example, Mr. Shapiro was friends with Mickey Kantor, the United States trade negotiator who would eventually be named a Monsanto director. Confrontation in trade negotiations became the order of the day. Senior administration officials publicly disparaged the concerns of European consumers as the products of conservative minds unfamiliar with the science. "You can't put a gun to their head," Mr. Harbison said of the toughened trade strategy with Europe. "It just won't sell." And it didn't. Protests erupted in Europe, and genetically modified foods became the rallying point of a vast political opposition. Exports of the foods slowed to a stop. With a vocal and powerful opposition growing in both Europe and America, the perceived promise of biotechnology foods began to slip away. By the end of the decade, the magnitude of Monsanto's error in abandoning its slow, velvet-glove strategy of the 1980's was apparent. Mr. Shapiro himself acknowledged as much. In the fall of 1999, he appeared at a conference sponsored by Greenpeace, the environmental group and major biotechnology critic. There, while declaring his faith in biotechnology, Mr. Shapiro acknowledged that his company was guilty of "condescension or indeed arrogance" in its efforts to promote the new foods. But it was too late for a recovery. Soon after that speech, with the company's stock price in the doldrums because of its struggles with agricultural biotechnology, Monsanto itself ended its existence as an independent company. It was taken over by Pharmacia, a New Jersey drug company. In recent months, biotechnology has been struggling with the consequences of its blunders. Leading food companies like Frito-Lay and Gerber have said they will avoid certain bioengineered food. And grain companies like Archer Daniels Midland and Cargill have asked farmers to separate their genetically modified foods from their traditional ones. That, in turn, creates complex, costly and - as the Starlink fiasco shows - at times flawed logistical requirements for farmers. Efforts have been made by industry and government to assuage public concerns - although critics of the technology maintain that the attempts do not go far enough. Last week, the F.D.A. announced proposed rule changes requiring the submission of certain information that used to be provided voluntarily. But even supporters of the rule change say that it will make little practical difference in the way the business works, since companies have universally submitted all such information in the past, even under the voluntary standard. And the industry itself has started down a new path, with a multimillion-dollar advertising campaign promoting genetically engineered foods as safe products that provide enormous benefits to populations around the world - an effort that some food industry officials say has come 10 years too late. Attorneys made policy not science! To Richard Kock, Recently read your thoughts on the saga die-off. "The animals in these outbreaks were eating mainly wheat grass from my limited examination of grazed plants and a few more of their normal food plants – no evidence for pure plant toxicity remember they are highly selective feeders! But pasture analysis would help including toxicology to rule this out and also looking at other potential toxic factors.” Since most of the wheat is grown in Kostanai and that is where most animals expired it seems to be relevant when looking for cause. I also looked into the the who, what, when and where of gmo wheat being produced in Kazakhstan. It was devastating to say the least. Just one look at the corruption that has enabled Monsanto to procure gmo wheat and then pass off other wheat crops as organic “was” evidenced here by this purveyor: http://www.alibaba.com/trade/search?fsb=y&IndexArea=product_en&CatId=&SearchText=wheat+flour+kazakhstan The wheat that is described below was copied and pasted yesterday and is no longer on the alibaba website today? Just looked for this variety and it is gone! Feed WheatFeed Wheat can get all the nutrients we need from food alone Country of origin: Kazakhstan Type of oil: Refined oil Ingredients: GMO Refined: Tare- 5 litrovye bottles The NCBI states: Abstract http://www.ncbi.nlm.nih.gov/pubmed/17987446 According to the information reported by the WHO, the genetically modified (GM) products that are currently on the international market have all passed risk assessments conducted by national authorities. These assessments have not indicated any risk to human health. In spite of this clear statement, it is quite amazing to note that the review articles published in international scientific journals during the current decade did not find, or the number was particularly small, references concerning human and animal toxicological/health risks studies on GM foods. In this paper, the scientific information concerning the potential toxicity of GM/transgenic plants using the Medline database is reviewed. Studies about the safety of the potential use of potatoes, corn, soybeans, rice, cucumber, tomatoes, sweet pepper, peas, and canola plants for food and feed were included. The number of references was surprisingly limited. Moreover, most published studies were not performed by the biotechnology companies that produce these products. This review can be concluded raising the following question: where is the scientific evidence showing that GM plants/food are toxicologically safe? When are scientist going to stop being confounded for not doing the proper research and when are the truly great scientist that have done the research going to be recognized instead of being ostracized? Thank you for your time, Best regards, Stop the agricultural warfare! Stop using the planet as a source for the greediest nihilist in our society who own and profit from life.

dhinds Comment left 23rd June 2015 05:05:48
Reinventing evolution for corporate gain (a fundamentally dishonest goal) has led to reinventing (or rewriting) history for the same sociopathic motive. For that reason I am glad to see the Institute for Science in Society coordinate it's efforts with Steven Druker, Gilles-Eric Seralini and other scientists and socially responsible communicators committed to exposing the hoax of Recombinant Genetic Modification, which is the antithesis of both Substantially Equivalent to conventional breeding and the embodiment of Science in the Corporate Interest. "Unraveling the DNA Myth: The Spurious Foundation of Genetic Engineering" by Barry Commoner (published in Harpers in February of 2002 and available at http://www.gmo-free-regions.org/fileadmin/_temp_/UnrvlDNAmyth.pdf) is another clear refutation that clearly explains why genetic engineering is unable to fulfill the promises that the biotech industry's propaganda machine has foisted on a gullible public.

Theresa Comment left 23rd June 2015 05:05:19
Thank you for this article. The US GM regulation public "stakeholder engagement" ends tonight midnight (eastern time). Appears to be open to all countries. This is worth keeping an eye on. http://www.regulations.gov/#!docketDetail%3bD=APHIS-2015-0036 If anyone has something to say and misses the deadline, I don't see any harm in writing even after the deadline. It appears to have fallen under the radar of many and this can be pointed out in any late comments. Cross contamination effects everyone everywhere but many will be unaware that they can comment. I am not sure if Steven Druker is aware?